We don’t just build technology. We build hope for everyone dealing with cancer.

What You’ll do at Elekta

The Human Factors / Usability Engineer is responsible for providing expert guidance and required documentation regarding human factors engineering and usability testing during product development and product lifecycle to ensure the products are safe, effective and user-friendly, in compliance with regulations and applicable standards (such as MDR, FDA, IEC 62366, and ISO 14971).

Responsibilities:

• Lead and coordinate Human Factors Engineering (HFE) / Usability Engineering (UE) activities to assure regulatory compliance, safe and effective solutions, as well as to provide world class experiences for our customers.
• Ensure a proper integration of HFE/UE and UX/UI design principles into product design, design controls and risk management activities throughout the development process and product lifecycle.
• Define usability strategies, and plan, conduct, analyze and report user research and usability evaluations (formative and summative) to inform design decisions. Conduct root cause analysis and make improvement proposals based on evaluation results.
• Write and review technical documentation, including product documentation (e.g., Usability Engineering File, Risk Analysis, Instructions for Use, etc.).
• Perform and collaborate on use-error analysis and risk assessments, residual risk evaluations, ensure clear traceability to risk management files and risk control measures/mitigations, and ensure that use-related hazards are identified, mitigated, and validated as acceptable before product release.
• Collaborate with peers and cross-functional teams (hardware/software engineers, systems engineers, safety engineers, clinical and regulatory affairs, verification & validation, technical writers) to ensure proper application of HFE/UE and UX/UI design principles to products and components in which user feedback and PMS data are demonstrably used. This to ensure risk mitigation of use errors and continuous improvement of products.
• Further developing the HFE/UE discipline and process together with peers, including user research and UX/UI aspects.
• Provide training to colleagues with respect to HFE/UE and UX/UI understanding, fostering a culture of continuous learning and professional development.
• Keeping up to date with new developments and regulations in the field of HFE/UE (incl. UX/UI) for medical devices and inform colleagues about these.

Accountable for:

• Keeping the Usability Engineering File (UEF) up to date and ensuring that the UEF contains all necessary documentation for regulatory submissions and is properly integrated into the technical documentation/DDFs.
• Proactively contributing to the development and continuous improvement of products, components and processes in the field of HFE/UE and UX/UI.

What you’ll bring

Education:

• Master’s degree in Human Factors, Cognitive Psychology, Industrial Engineering, Biomedical Engineering or comparable.

Experience & Knowledge:

• At least 3 years of experience in human factors / usability engineering, conducting usability evaluations during product development of mechatronic devices in a regulated industry, preferably medical devices.
• Strong knowledge of HFE/UE and UX/UI design principles and methodologies.
• Comprehensive knowledge of HFE/UE activities (such as performing HF/UE analyses, preparing and executing formative and summative evaluations, and reporting).
• Experience with Quality Management Systems, electronic document control and Agile / Scrum.
• Knowledge of medical device regulations and standards (MDR, FDA, ISO 13485, ISO 14971, IEC 62366).
• Knowledge of clinical workflows, medical imaging and/or radiation therapy, and regulatory approval processes are considered a plus.

Skills & Competencies:

• Strong analytical, problem solving, and technical writing skills.
• Strong interpersonal and communication skills in English, and preferably in Dutch as well.
• Creative, accurate and results-driven. Contributing effectively towards a joint result, even when the topic involved does not directly serve one’s own interest.
• Proficient in analyzing complex user workflows and translating findings into actionable design inputs.
• Proficient in working with HFE/UE tools, UI design, data analysis and collaboration tools (e.g. Microsoft 365, Figma, Jira, Polarion).
• Proactive attitude; self-starting in recognizing opportunities and realizing improvements.
• Collaborate effectively across multidisciplinary teams.
• Commitment to advancing brachytherapy, improving clinical outcomes, accelerating product development, and continuous professional development.

Why should you join Elekta?

In this role, you will work for a higher purpose: hope for everyone dealing with cancer and for everyone, regardless of where they are in the world, to have access to the best cancer care. The internship is compensated, and the benefits package is provided in accordance with local regulations.

We are an equal opportunity employer

We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, genetic information, national origin, disability, veteran status, or any other status protected by law in the locations where Elekta operates.

About Elekta

As a leader in precision radiation therapy, Elekta is committed to ensuring every patient has access to the best cancer care possible. Elekta is a proud innovator and supplier of equipment and software used to improve, prolong, and save the lives of people with cancer and brain disorders.

More than 6,000 hospitals worldwide rely on Elekta technology. We openly collaborate with customers to advance sustainable, outcome-driven, and cost-efficient solutions to meet evolving patient needs, improve lives and bring hope to everyone dealing with cancer. To us, it’s personal, and our global team of 4,700 employees combine passion, science, and imagination to profoundly change cancer care. We don’t just build technology, we build hope.